Related Conditions:

Recruiting Status:

Phase:

URL:

Trial Eligibility

Document

Title

Brief Title: A Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies

Official Title: Open Label Phase 1/2 Trial of Tisotumab Vedotin in Japanese Subjects With Advanced Solid Malignancies

Clinical Trial IDs

ORG STUDY ID:
GCT1015-06

SECONDARY ID:
innovaTV 206

NCT ID:
NCT03913741

Conditions

Solid Tumor

Interventions

Drug

Synonyms

Arms

tisotumab vedotin

Experimental tisotumab vedotin

Purpose

Open Label Phase 1/2 Trial of Tisotumab Vedotin in Japanese Subjects with Advanced Solid
Malignancies

Detailed Description

Part 1 of this trial will determine the maximum tolerated dose (MTD) and/or the recommended
Phase 2 dose (RP2D) and the safety profile of tisotumab vedotin in subjects with solid
malignancies. Part 2 of this trial will enroll subjects with cervical cancer to provide
further data on the safety, tolerability, PK and anti-tumor activity

Trial Arms

Name

Type

Description

Interventions

Experimental tisotumab vedotin

Experimental

Open label, single arm trial where tisotumab vedotin will be administered

tisotumab vedotin

Eligibility Criteria

Inclusion Criteria (Main):
- PART 1 ONLY: Subjects with locally advanced or metastatic solid tumors, who have
experienced disease progression while on standard therapy or are intolerant of, or not
eligible for, standard therapy.
- PART 2 ONLY: Subjects with extra-pelvic metastatic or recurrent cervical cancer
including squamous cell, adenocarcinoma or adenosquamous histology who have
experienced disease progressed on standard of care chemotherapy in combination with
bevacizumab, if eligible.
Patients must not have received more than 2 prior systemic treatment regimens for recurrent
or metastatic cervical disease.
- Measurable disease according to RECIST v1.1
- Must be at least 20 years of age on the day of signing informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Is not pregnant, breastfeeding, or expecting to conceive children within the projected
duration of the trial and for at least 6 months after the last trial treatment
administration
- Women of childbearing potential must agree to use adequate contraception during and
for 6 months after the last dose of trial treatment administration
- A man who is sexually active with a WOCBP and has not had a vasectomy must agree to
use a barrier method of birth control (Part 1 only)
- Must provide signed informed consent before any trial-related activity is carried out.
Exclusion Criteria (Main):
- PART 2 ONLY: Clinically relevant bilateral hydronephrosis which cannot be alleviated
by ureteral stents or percutaneous drainage.
- Known past or current coagulation defects leading to an increased risk of bleeding.
- Ongoing major bleeding.
- Has an active ocular surface disease at baseline. Subjects with prior history of
cicatricial conjunctivitis are ineligible